Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours

Phase 1 Unknown 192 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

NaSingle-groupOpen-labelTreatment

Summary

This study is an open, multi-dose, dose escalation and cohort expansion, phase Ⅰ study to investigate the safety, tolerability, efficiency, pharmacokinetics, immunogenicity of SG001 in subjects with advanced tumours.

Timeline

Start: 2019-05-23
Primary completion: 2022-09
Completion: 2023-03

Publications

Fang J, Jiang O, Li W, Lin J, Fang M, Li Q, Zhao W, Wang K, Shi H, Chen Z, Yu J, Xing X, Zhao M, Liu A, Wang W, Han Z, Xiang S, Zhang X, Li J, Zhou C. Phase 1b Multicenter Study of SG001, a Humanized Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors. Drug Des Devel Ther. 2025 Nov 24;19:10423-10435. doi: 10.2147/DDDT.S546663. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enlonstobart	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Enlonstobart	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Enlonstobart	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Enlonstobart	Monoclonal antibody	240 mg	Intravenous

Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours

Summary

Timeline

Publications

Drugs

Indications